Status:
COMPLETED
Effects of Resistant Starch Diet on the Gut Microbiome in Chronic Kidney Disease
Lead Sponsor:
University of Arkansas
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
Conditions:
Chronic Kidney Diseases
Eligibility:
All Genders
5-85 years
Phase:
NA
Brief Summary
The investigators want to learn more about how to help people who have chronic kidney disease (CKD). This study will increase the investigators understanding of how diet affects factors that can slow ...
Detailed Description
Chronic kidney disease (CKD), a progressive decline in kidney function, is a growing health problem: 13% of adults in the US have CKD. Among patients with CKD, the risk of progression to irreversible ...
Eligibility Criteria
Inclusion
- Adult
- Between the ages of 18 and 85 years old
- Glomerular filtration rate estimated by creatinine clearance (eGFR Cr):between 59 and 30 ml/min for stage 3 CKD patients
- Urine protein \< 1 gram per day by 24-hour protein collection or urine protein-to-creatinine ratio \<1 gram/gram or urine microalbumin to creatinine concentration less than 1000 mg/g.
- Children
- Between the ages of 5 and 17 years
- eGFR Cr between 30 and 59 (stage 3 CKD) using the revised Schwartz equation.
- Urine protein \< 1 gram per day by 24-hour protein collection or urine protein-to-creatinine ratio \<1 gram/gram.
Exclusion
- Adult
- Age older than 85 years
- eGFR Cr \> 59 ml/min or \< 30 ml/min
- History of renal transplant
- Subject with diabetes (as defined by patient report, taking medications for the treatment of diabetes or as reported in the medical record)
- Use of antibiotics within 1 month
- Use of laxatives within 1 month
- Inflammatory bowel disease
- Irritable bowel syndrome
- Colorectal cancer
- Surgically removed bowel or presence of an ostomy
- Pregnancy
- Inability to obtain written informed consent
- Constipation
- Diarrhea
- Children
- Age younger than 5 years
- eGFR \> 59 ml/min and \< 30 ml/min
- History of renal transplant
- Subject with diabetes (as defined by patient report, taking medications for the treatment of diabetes or as reported in the medical record)
- Use of antibiotics within 1 month
- Use of laxatives within 1 month
- Inflammatory bowel disease
- Surgically removed bowel or presence of an ostomy
- Pregnancy
- Constipation
- Diarrhea
Key Trial Info
Start Date :
February 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03356990
Start Date
February 12 2018
End Date
December 31 2024
Last Update
March 7 2025
Active Locations (1)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205